Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
88 participants
INTERVENTIONAL
2024-10-16
2026-06-30
Brief Summary
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Detailed Description
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Despite the prevalence of constipation and significant effect on quality of life, few studies have examined an evidence-based bowel regimen for postoperative constipation prevention in the Urogynecology population.
As per available medical literature, the onset of action for oral senna occurs within 6-12 hours, while bisacodyl suppository can take effect between 15 and 60 minutes following rectal administration. Proposed trial comparing oral senna to rectal bisacodyl suppositories for the prevention of postoperative constipation in women undergoing vaginal reconstructive surgery for symptomatic prolapse.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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SENNA
Group A participants will be prescribed oral senna (Senokot; Atlantis Consumer Healthcare Inc., Bridgewater, NJ) 8.6mg tablets and be instructed to start with two tablets on the morning of Post Operative Day (POD)#1. Participant will continue taking two tablets on the daily. If no bowel movement on the morning of POD#3 participant may take 2 tablets in the morning and another 2 tablets that evening. The same can be replicated on POD#4. If no bowel movement on the morning of POD#5 participant may take magnesium hydroxide (Phillips' Milk of Magnesia; Bayer AG, Leverkusen, Germany) 30 mL by mouth and need to call the urology clinic for further instruction.
Senna Tab
Senna 8.6mg two tablets per day post operative day 1 and and if needed, then continue on the same dose regiment until post operative day 5.
DULCOLAX
Group B participants will be prescribed bisacodyl rectal (Dulcolax Suppository; Sanofi S.A., Paris, France) 1 suppository to be placed rectally on the morning of Post Operative Day (POD)#1. Participant will continue placing a nightly rectal suppository until their first bowel movement. If no bowel movement by the morning of POD#5 participant may take magnesium hydroxide (Phillips' Milk of Magnesia; Bayer AG, Leverkusen, Germany) 30 mL by mouth and need to call the clinic for further instruction.
Dulcolax Suppositories
Dulcolax 1 suppository to be placed rectally on the evening of post operative day 1 and if needed, then continue using the same dose regiment until the post operative day 5.
Interventions
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Senna Tab
Senna 8.6mg two tablets per day post operative day 1 and and if needed, then continue on the same dose regiment until post operative day 5.
Dulcolax Suppositories
Dulcolax 1 suppository to be placed rectally on the evening of post operative day 1 and if needed, then continue using the same dose regiment until the post operative day 5.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Those unable to provide consent
* Preexisting chronic laxative use
* Conditions that could affect bowel function including, inflammatory bowel disease, irritable bowel syndrome, colorectal cancer, rectovaginal fistula; concurrent bowel surgery; intraoperative bowel injury
18 Years
FEMALE
No
Sponsors
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Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Candace Parker-Autry, MD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Caljouw MA, Hogendorf-Burgers ME. GYNOTEL: telephone advice to gynaecological surgical patients after discharge. J Clin Nurs. 2010 Dec;19(23-24):3301-6. doi: 10.1111/j.1365-2702.2010.03395.x. Epub 2010 Oct 14.
Ramaseshan AS, LaSala C, O'Sullivan DM, Steinberg AC. Patient-Initiated Telephone Calls in the Postoperative Period After Female Pelvic Reconstructive Surgery. Female Pelvic Med Reconstr Surg. 2020 Oct;26(10):626-629. doi: 10.1097/SPV.0000000000000636.
Arya LA, Novi JM, Shaunik A, Morgan MA, Bradley CS. Pelvic organ prolapse, constipation, and dietary fiber intake in women: a case-control study. Am J Obstet Gynecol. 2005 May;192(5):1687-91. doi: 10.1016/j.ajog.2004.11.032.
Patel M, Schimpf MO, O'Sullivan DM, LaSala CA. The use of senna with docusate for postoperative constipation after pelvic reconstructive surgery: a randomized, double-blind, placebo-controlled trial. Am J Obstet Gynecol. 2010 May;202(5):479.e1-5. doi: 10.1016/j.ajog.2010.01.003. Epub 2010 Mar 6.
Tarumi Y, Wilson MP, Szafran O, Spooner GR. Randomized, double-blind, placebo-controlled trial of oral docusate in the management of constipation in hospice patients. J Pain Symptom Manage. 2013 Jan;45(1):2-13. doi: 10.1016/j.jpainsymman.2012.02.008. Epub 2012 Aug 11.
Other Identifiers
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IRB00110733
Identifier Type: -
Identifier Source: org_study_id
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